MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) status: preamendment.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that the implanted ultrathane mac-loc locking loop biliary drainage catheter was leaking from the junction between the luer lock portion of the device and the catheter meet, where the two pieces can be screwed together or unscrewed.The device was subsequently replaced.The device was being placed in the liver for a biliary drainage indication.The complaint device was in place for 37 days prior to its removal.The device has been received for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Additional information: patient identifier.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection / functional test of the returned device were conducted during the investigation, and no systemic issues were found related to the reported issue.One catheter was returned with no obvious biomatter present.The mac-loc was in the locked position.No cracks or defects were observed on the proximal assembly.One thread was present between the mac-loc and cap.The cap and tubing were not able to be pulled or twisted within the proximal assembly.Marks similar to those created by hemostats were observed on the cap.Hemostats were then used to clamp off the catheter in order to pressurize the proximal assembly.Immediately upon pressurization, water leaked from the between the cap and mac-loc threads.Therefore, the leakage failure was able to be duplicated.Additionally, a document-based investigation evaluation was performed.Several risk controls are in place for this product.There is no evidence to suggest the product was not made to specifications.A review of the main work order ((b)(4)) found 4 nonconformances.There were 2 nonconformances related to bad forming, which were scrapped.There was 1 nonconformance for a bent obturator, which was scrapped.There was 1 nonconformance for foreign matter on catheter tip, which was scrapped.The workorder for the mac-loc subassembly ((b)(4)) found 0 nonconformances.The workorders confirmed that qc was performed on the devices.All nonconformances observed were scrapped.Due to the individual nature of the manufacturing process, a nonconformance in one device does not indicate a nonconformance in the rest of the lot.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been initiated to correct this issue.Monitoring will continue to be performed for similar complaints.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7098264
• MDR Text Key: 94193152
• Report Number: 1820334-2017-04159
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)200706(10)8042444
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention